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Generated: September 21, 2018

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CLINICAL TRIALS PROFILE FOR CLOFIBRATE

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Clinical Trials for Clofibrate

Trial ID Title Status Sponsor Phase Summary
NCT00000482 Coronary Drug Project Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 To determine whether regular administration of lipid modifying drugs (clofibrate, nicotinic acid, estrogen, dextrothyroxine) to men with a documented myocardial infarction would result in significant reduction in total mortality over a five year period. Secondarily, to determine whether the degree to which these drugs changed serum lipids was correlated with any effect on mortality and morbidity rates; to gain further information on the long-term prognosis of myocardial infarction (by studying the control group as intensively as the treatment group); to acquire further experience and knowledge concerning the techniques and methodology of long-term clinical trials; to determine, in a substudy, the effectiveness of aspirin, a platelet inhibitor, in reducing recurrences of myocardial infarction.
NCT00000483 Coronary Drug Project Mortality Surveillance Completed National Heart, Lung, and Blood Institute (NHLBI) N/A To determine whether there were any long term sequelae of the drugs used in the Coronary Drug Project (estrogens, dextrothyroxine, nicotinic acid, clofibrate).
NCT00238004 The Low HDL On Six Weeks Statin Therapy (LOW) Study Unknown status Craigavon Area Hospital Phase 4 Abnormal blood cholesterol levels increase the risk of developing, or dying from heart disease. It is well recognised that if "harmful" LDL cholesterol is high, and "protective" HDL cholesterol is low, this risk is increased. Drugs called statins are routinely used in patients with heart disease, are well tolerated, and decrease the harmful LDL cholesterol levels. However, statins only increase protective HDL cholesterol to a small extent. Some patients may thus benefit from additional medication to increase protective HDL-cholesterol further. One of the most effective drugs which can do this is nicotinic acid. This drug is well established having been available for over 30 years. Previous use has been limited by facial flushing in a large percentage of patients receiving the drug. However a new formulation called Niaspan is now available which is associated with much less flushing. Although many patients will have transient flushing, it is estimated that only 1 patient out of every 20 receiving the drug will have to discontinue treatment. We therefore propose, in patients with coronary artery disease and low HDL cholesterol despite being on a statin, to study the effect of Niaspan on HDL cholesterol and other lipid parameters, and to assess its tolerability.
NCT00311987 Study of 3,5-Diiodothyropropionic Acid (DITPA) in Hypercholesterolemic Patients Terminated Johns Hopkins University Phase 1/Phase 2 The natural thyroid hormones, thyroxine (T4) and triiodothyronine (T3), are known to have a cholesterol-lowering effect. Their pharmacologic use for this purpose is limited, however, by their actions on other organs, including the heart, bone, and brain, where there can be side effects of excessive thyroid hormone action. 3,5-diiodothyropropionic acid (DITPA) is a thyroid hormone analog with relative selectivity for a form of the thyroid hormone receptor expressed in the liver, where it regulates several aspects of lipid metabolism, including the clearance of low-density lipoprotein (LDL) cholesterol. This study is designed to determine whether DITPA is safe and effective in achieving LDL cholesterol levels that are consistent with the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guidelines in patients who have not achieved those levels on conventional therapy, due to drug-resistant disease, drug intolerance, or both. This is a single-center, randomized, double-blind, placebo-controlled study. Following a 4-week Pre-Randomization Phase with dietary counseling and a 2-week placebo run-in, eligible patients will be randomized (1:1:1) to receive DITPA (90 mg/day, 180 mg/day), or placebo for a total treatment duration of 12 weeks. Sixty (60) patients will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio (i.e., 20 patients per treatment group): - DITPA at 90 mg/day (45 mg twice a day [BID] taken orally) - DITPA at 180 mg/day (90 mg BID taken orally) - Placebo (BID taken orally) Those patients randomized to receive DITPA at 90 mg/day will receive 45 mg/day for the first 2 weeks, followed by 90 mg/day for 10 weeks. Those patients randomized to receive DITPA at 180 mg/day will receive 45 mg/day for the first 2 weeks, followed by 90 mg/day for the next 2 weeks, and then 180 mg/day for 8 weeks.
NCT00983788 Effect of Bezafibrate on Muscle Metabolism in Patients With Fatty Acid Oxidation Defects Completed Groupe Hospitalier Pitie-Salpetriere Phase 2 The investigators propose to evaluate the effect of bezafibrate on metabolism during exercise in 22 adult patients affected with carnitine palmitoyltransferase II (CPTII) or very-long chain acyl-CoA-dehydrogenase (VLCAD) deficiencies. This study will be an 9-month, randomized, double-blind, placebo-controlled crossover trial. The trial will be conducted in two centers: Institut de Myologie, Pitié-Salpêtrière Hospital in France, and Rigshospitalet, University of Copenhagen, in Denmark. The main criteria for assessing the potential effect of this drug will be the fat oxidation rate studied during a moderate workload on cycle ergometer, after infusion of stable isotopes (palmitate and glucose tracers).
NCT00983788 Effect of Bezafibrate on Muscle Metabolism in Patients With Fatty Acid Oxidation Defects Completed Rigshospitalet, Denmark Phase 2 The investigators propose to evaluate the effect of bezafibrate on metabolism during exercise in 22 adult patients affected with carnitine palmitoyltransferase II (CPTII) or very-long chain acyl-CoA-dehydrogenase (VLCAD) deficiencies. This study will be an 9-month, randomized, double-blind, placebo-controlled crossover trial. The trial will be conducted in two centers: Institut de Myologie, Pitié-Salpêtrière Hospital in France, and Rigshospitalet, University of Copenhagen, in Denmark. The main criteria for assessing the potential effect of this drug will be the fat oxidation rate studied during a moderate workload on cycle ergometer, after infusion of stable isotopes (palmitate and glucose tracers).
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Clofibrate

Condition Name

Condition Name for Clofibrate
Intervention Trials
Myocardial Infarction 2
Cardiovascular Diseases 2
Heart Diseases 2
Coronary Disease 2
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Condition MeSH

Condition MeSH for Clofibrate
Intervention Trials
Coronary Artery Disease 3
Myocardial Ischemia 3
Cardiovascular Diseases 2
Myocardial Infarction 2
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Clinical Trial Locations for Clofibrate

Trials by Country

Trials by Country for Clofibrate
Location Trials
United Kingdom 1
Canada 1
Denmark 1
United States 1
Brazil 1
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Trials by US State

Trials by US State for Clofibrate
Location Trials
Maryland 1
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Clinical Trial Progress for Clofibrate

Clinical Trial Phase

Clinical Trial Phase for Clofibrate
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Clofibrate
Clinical Trial Phase Trials
Completed 5
Terminated 1
Unknown status 1
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Clinical Trial Sponsors for Clofibrate

Sponsor Name

Sponsor Name for Clofibrate
Sponsor Trials
National Heart, Lung, and Blood Institute (NHLBI) 2
Craigavon Area Hospital 1
Federal University of São Paulo 1
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Sponsor Type

Sponsor Type for Clofibrate
Sponsor Trials
Other 7
NIH 2
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Argus Health
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